# FDA 483 - FujiFilm Diosynth Biotechnologies U.S.A., Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-usa-inc/866350c6-96dd-4459-961a-5276a841f01c

> FDA 483 for FujiFilm Diosynth Biotechnologies U.S.A., Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FujiFilm Diosynth Biotechnologies U.S.A., Inc.
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Fujifilm Diosynth Biotechnologies in Morrisville, NC, from October 22-26, 2018, revealed significant deficiencies in quality control and manufacturing processes. Observations included inconsistencies in release testing specifications, inadequate materials management with expired items, and systemic failures in deviation investigation and CAPA implementation. Additionally, laboratory controls for analytical methods, particularly peak integration, were found to be insufficient.

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## Related Officers

- [Steven Tong, Ph.D. (lead)](https://www.keypedia.com/people/steven-tong-phd-lead/3a67a6b5-c323-43b7-80bc-303575abe1d3)
- [investigator](https://www.keypedia.com/people/ashutosh-rao/534cf8b7-540c-431d-b72f-9ac4a8e3a439)
- [issuing_officer](https://www.keypedia.com/people/xuhong-li/876f0dd0-cf98-42fe-b544-8cf8ab5e084b)
- [Zhenzhen Liu](https://www.keypedia.com/people/zhenzhen-liu/e166c0fc-7555-49ff-ad84-e9be50c542ce)
- [issuing_officer](https://www.keypedia.com/people/amy-a-devlin/fed31d2d-96d0-4849-a167-92bec5d6d2be)

Company: https://www.keypedia.com/companies/fujifilm-diosynth-biotechnologies-usa-inc/44b7fa9f-848c-4e30-869e-12ddcfd848f8

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321